14 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
MPS-Medizinische Planungssysteme GmbH
Manufacturer
🇩🇪 Germany
midge Medical MPS GmbH
Manufacturer
🇩🇪 Germany
Strama-MPS Maschinenbau GmbH & Co. KG
Manufacturer
🇩🇪 Germany
SAMPLING.pro
Device
EU IVDR
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Eu Ivd Class A
·BIOMES NGS GmbH·On the market
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
FDA Enforcement
Class II
·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016
SAMPLING.pro
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·BIOMES NGS GmbH·1 device
Novanta Europe GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
OHST Medizintechnik Aktiengesellschaft
Importer
🇩🇪 Germany·2 Manufacturers
MPS Medical Product service GmbH
Importer
🇩🇪 Germany·2 Manufacturers
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
NDS Surgical Imaging LLC - Zweigniederlassung Deutschland
Authorized representative
🇩🇪 Germany
Centrifuge 5920R
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Eppendorf SE·6 devices